MAUDE Adverse Event Report: U.S. SURGITECH INC SURGYCUT; SURGYCUT L - WIRE WITH HANDLE ELECTRODE 5MM / 35CM

Model Number	790-110-535
Medical Device Problem Code	Solder Joint Fracture (2324)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The electrode tip was discarded by the facility, the remaining sample was returned for evaluation.The part from where the tip broken was carefully examined under the microscope.There were no micro cracks in the broken area which could lead to any manufacturing detects.Furthermore, device history records were also checked by the contract manufacturer for any production related issues which showed no abnormality in the manufacturing process.Samples from same lot in the warehouse were also checked and found adequate.Contract manufacturer has been asked to increase the inspection of the tips with the electrodes shaft.The procedure lasted for 5 hr 30 mins in which this electrode was used and there is a possibility of electrode being used unexpectedly as no manufacturing fault is detected.The incident is a standalone incident as there have been no complaints received in the past about this product or same issue.If there is more information or complaints received, futher actions will be taken accordingly.At this stage, the complaint is standalone and no issues in the manufacturing or quality control are deteched.
Event or Problem Description
Doctor was working with the electrode inside the abdominal cavity when the tip of the device deattached.Fortunately, doctor noticed it and retrived it immediately with no consequences.

• Brand Name: SURGYCUT
• Common Device Name: SURGYCUT L - WIRE WITH HANDLE ELECTRODE 5MM / 35CM
• Manufacturer (Section D): U.S. SURGITECH INC; 551 kimberly drive; carol stream; chicago IL 60188
• Manufacturer (Section G): HANGZHOU TONGLU SHIKONGHOU MEDICAL INSTRUMENTS CO.; 100 sangyuan raod, tonglu; hangzhou; tonglu, zhejiang 31150 0; CH 311500
• Manufacturer Contact: hammad yousaf ; 551 kimberly drive; carol stream; chicago, IL 60188 ; 8009704877
• MDR Report Key: 20425744
• Report Number: 3004777218-2024-00006
• Device Sequence Number: 12888315
• Product Code: GEI
• UDI-Device Identifier: 00810014631288
• UDI-Public: 00810014631288
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K911316
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2026
• Device Model Number: 790-110-535
• Device Catalogue Number: 790-110-535
• Device Lot Number: 20230725
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2024
• Initial Report FDA Received Date: 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 116 KG